Application 204442

Type: NDA
Sponsor: TITAN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROBUPHINE	BUPRENORPHINE HYDROCHLORIDE	IMPLANT;IMPLANTATION	EQ 80MG BASE/IMPLANT	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204442-001	PROBUPHINE	BUPRENORPHINE HYDROCHLORIDE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION		RLD	2016-05-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2016-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2016-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2016-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2016-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2016-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204442-001	PROBUPHINE	EQ 80MG BASE/IMPLANT	IMPLANT / IMPLANTATION	RLD	2016-05-26	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204442-001	7736665	2024-04-25	U-1878	2016-07-25	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204442-001	NP	2019-05-26	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204442-001	NP	2019-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204442-001	NP	2019-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204442-001	NP	2019-05-26	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Advagen Pharma Ltd	699638dd-3a53-445f-a545-d0e6eabfe1c9	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	9f7b0a28-f937-4d4d-b793-ca3468bd28e0	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
BELBUCA	BUPRENORPHINE HYDROCHLORIDE	BioDelivery Sciences International Inc	bc2b7a3d-72cf-497c-95b0-ba2b71f63c64	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hospira, Inc.	23aa1bb3-cecf-4e62-29bb-48488bb66fc3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Par Health USA, LLC	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	adc1167e-910e-4d7b-abdc-751d3df0c3dc	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	74e40c51-853b-4e7f-b3cb-a27af29e1cbf	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
52440-100	Probuphine	buprenorphine hydrochloride	Titan Pharmaceuticals, Inc.	NDA	Current
58284-100	Probuphine	buprenorphine hydrochloride	Braeburn Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84659	SUPPL	2026-01-06
84578	SUPPL	2025-12-29
77076	SUPPL	2023-12-19
76970	SUPPL	2023-12-18
76969	SUPPL	2023-12-18
73855	SUPPL	2023-03-24
73840	SUPPL	2023-03-24
71407	SUPPL	2022-06-21
71406	SUPPL	2022-06-21
71375	SUPPL	2022-06-21
66726	SUPPL	2021-03-10
66611	SUPPL	2021-03-08
60480	SUPPL	2019-10-09
60479	SUPPL	2019-10-09
60461	SUPPL	2019-10-09
56302	SUPPL	2018-11-06
55493	ORIG	2018-09-18
52395	ORIG	2018-02-05
52290	SUPPL	2018-02-02
52243	SUPPL	2018-02-01
49155	SUPPL	2017-07-31
49154	SUPPL	2017-07-31
48082	SUPPL	2017-04-21
45818	APPL	2016-11-04
32561	ORIG	2016-05-26
19562	ORIG	2016-05-26